BEUDAMED
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    ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS(NCP(R)) SYSTEM

    Research and Diagnostic Systems

    FDA UDI
    RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020315·CBC-5D: 12 x 5mL TriPack (4 each Level 1, 2, 3)

    Research and Diagnostic Systems

    FDA UDI
    RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020117·CBC-3D: 12 x 2mL TriPack (4 Low, 4 Normal, 4 High)

    CELL-DYN

    FDA UDI
    ABBOTT LABORATORIES·00380740020323·CELL-DYN 18 PLUS CONTROL

    Advanced Instruments GloCyte® High Level Control Vial (Single)

    FDA UDI
    ADVANCED INSTRUMENTS, INC.·00816068020191·3 mL vial of High Level Control

    Research and Diagnostic Systems

    FDA UDI
    RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020353·CBC-7: 10 x 2mL Dual Pack (5 Low, 5 High)

    COULTER 4C-ES

    FDA UDI
    Beckman Coulter, Inc.·15099590222314·COULTER 4C-ES Plus Cell Control

    Alinity

    FDA UDI
    Abbott GmbH·00380740151270·ALINITY h-series CONTROL 29P

    COULTER 4C-ES

    FDA UDI
    Beckman Coulter, Inc.·15099590222277·COULTER 4C-ES Plus Cell Control

    CVA for CellDyn

    FDA UDI
    STRECK, INC.·00844509001584·Assayed linearity control kits that are used to...

    QBC Diagnostics

    FDA UDI
    DRUCKER DIAGNOSTICS·00858092006543·QBC Extended Range Hematology Controls

    Para 12 Plus

    FDA UDI
    STRECK, INC.·00844509000228·A whole blood hematology control specifically f...

    CDS™ 3-PD Hematology Control

    FDA UDI
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.·00812137010247·For in vitro diagnostic use as a control to mon...

    Research and Diagnostic Systems

    FDA UDI
    RESEARCH AND DIAGNOSTIC SYSTEMS, INC.·00815762020698·CBC-LINE Kit: 6 x 3mL (6 vials each of the var...

    e-CHECK

    FDA UDI
    SYSMEX CORPORATION·14987562460288·E-Check 4X4.5MLX3 Low/Normal/High

    Para 4

    FDA UDI
    STRECK, INC.·00844509000785·A multi-parameter hematology control for small ...